Guideline on prescribing infant formula
for infants with Cows’ Milk Protein
Allergy (CMPA)
Produced by: Dietitians Joanna Padfield, Sue Perry, Ravina Krishan and the
Medicines Management team, as a part of collaborative working between NHS
Barking and Dagenham, Havering and Redbridge Clinical Commissioning Groups
(BHR CCGs) and NHS North East London Foundation Trust (NELFT)
Approved by: BHR Area Prescribing sub-Committees January 2016
Review date: January 2019
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Contents
Page
Aim
3
Introduction
3
Lactose intolerance
4
Breast milk
4
Symptoms and diagnosis
5
Treatment






Breastfeeding
Extensively hydrolysed formulae
Amino acid formulae
Soy formulae
Unsuitable formulae
Quantities to prescribe
5
6
7
8
9
9
Referral to dietetics and specialist services
10
Reviewing and discontinuing treatment
11
References and evidence
12
Appendices


Appendix 1 – quick reference guide to calcium
supplementation with hypoallergenic formulae
Appendix 2 – quick reference guide to prescribing
hypoallergenic formulae for cow’s milk protein allergy
13
14
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Aim of the guidelines
To provide GPs and allied health professionals with guidelines on the safe,
appropriate and cost effective initiation and monitoring of infant formula for children
with cows’ milk protein allergy (CMPA).
Objectives
1. To understand the:
 Type and quantity of formula to prescribe
 Range of products available and their costs
 Criteria for referral to the Community Nutrition and Dietetics Service and/or
secondary/specialist care
 Review process and criteria for discontinuing prescriptions
2. To be able to access the evidence base for the guidelines.
Introduction
It is estimated that 1.9 - 4.9 percent of infants and young children have cows’ milk
protein allergy (CMPA), making it one of the most common food allergies in this age
group (Venter C, Arshad SH; 2011). Specialised hypoallergenic formulas can be
prescribed for infants with CMPA in order to resolve symptoms and ensure optimal
growth and development (Fiocchi A et al; 2010). There are 2 main types of
hypoallergenic formulae:


Extensively hydrolysed formulas (EHF). The protein is broken down into
peptides. These are tolerated by 90% of infants with CMPA (Allen KJ,
Davidson GP, Day AS, et al; 2009).
Amino acid formulas (AAF). The protein is broken down into individual
amino acids. They provide an alternative for children who do not tolerate EHF
or those with severe symptoms.
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Lactose intolerance
Lactose intolerance occurs when the infant has insufficient lactase enzyme to be
able to digest milk sugar. The symptoms of lactose intolerance include stomach pain,
diarrhoea, a bloated stomach and excessive wind. These symptoms usually occur
within 1–3 hours after taking milk. In this case, the infant will require a lactose free
formula, Extensively Hydrolysed Formulae (EHF) or Amino Acid Formulae
(AAF) are not required unless CMPA is also present.
**Please note that Lactose Intolerance is not the
same as CMPA**
Breast milk first
Breast milk remains the optimal milk for infants. This should be promoted and
encouraged where it is clinically safe to do so and the mother is in agreement.
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Signs and symptoms
Most infants with CMPA develop symptoms within 1 week of introduction of a CMP based formula.
Signs and symptoms of possible food allergy (NICE guidelines CG116; 2011)
IgE-mediated
The skin
Pruritus
Erythema
Acute Urticaria – localised or
generalised
Acute angioedema – most commonly
of the lips, face and around the eyes
The Gastrointestinal system
Angiodema of the lips, tongue and
palate
Oral pruritus
Nausea
Colicky abdominal pain
Vomiting
Diarrhoea
Non-IgE-mediated
Pruritis
Erythema
Atopic eczema
Gastro-oesophageal reflux disease
Loose or frequent stools
Blood and/or mucus in stools
Abdominal pain
Infantile colic
Food refusal or aversion
Constipation
Perianal redness
Pallor and tiredness
Faltering growth in conjunction with at least
one or more gastrointestinal symptoms
above (with or without significant atopic
eczema)
The respiratory system (usually in combination with one or more of the above
symptoms and signs)
Upper respiratory tract symptoms
(nasal itching, sneezing, rhinorrhoea,
or congestion [with or without
conjunctivitis])
Lower respiratory tract symptoms
(cough, chest tightness, wheezing or
shortness of breath)
Other
Signs or symptoms of anaphylaxis or
other systemic reactions
Refer to NICE guideline CG116 ‘Food Allergy in Children and Young People’ Feb
2011 for full details on symptoms and diagnosis.
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Treatment
Breastfeeding

Although only 0.5% of exclusively breastfed infants show reproducible reactions
to cows’ milk protein (CMP), symptoms may present as they react to the milk
protein from the maternal diet (Vandenplas et al 2007). Breastfeeding should be
encouraged to continue, and a maternal CMP exclusion diet trialled for a
minimum of 2 weeks. Breastfeeding mothers on a CMP exclusion diet should be
assessed to ensure the maternal diet is adequate and may require
supplementation with 1000mg calcium per day.
Formula feeding
If the mother is NOT breastfeeding, Extensively Hydrolysed Formulae (EHF) should
be prescribed as the first line.
Extensively Hydrolysed Formulae (EHF)
EHF
Age group
Cost (September 2015)
First line and alternatives
First Line:
from birth
400g = £9.10
Similac Alimentum® (Abbott)
Nutramigen 1 ® (Mead Johnson) from birth
400g = 10.87
®
Nutramigen 2 (Mead Johnson) from 6 months
400g = 10.87
Lactose containing formulas These may be used where gastrointestinal
symptoms are NOT present
®
Aptamil Pepti 1 (Milupa)
from birth
400g = £9.74
800g = £19.40
®
Aptamil Pepti 2 (Milupa)
from 6 months
400g = £9.29
800g = £18.58
®
SMA Althera (Nestle Health
from birth
450g = £10.68
Science)
EHF with medium chain triglycerides. Should only be started in
secondary care. May be used where CMPA is accompanied by malabsorption
Pregestimil Lipil® (Mead
from birth
400g = £12.06
Johnson)
Pepti Junior® (Cow and Gate)
from birth
450g = £12.89
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Amino Acid Formulae (AAF)
AAFs are suitable only:




If EHF does not resolve symptoms within 4 weeks
and/or
There is a history of anaphylactic reaction
and/or
Faltering growth in addition to severe GI symptoms
Reaction to CMP in breast milk and the mother does not wish to continue
breastfeeding
AAF
Age group
Cost (correct
Notes
September 2015)
First line
SMA Alfamino® (Nestle
Health Science)
Nutramigen PURAMINO®
(Mead Johnson)
Neocate LCP® (Nutricia)
High calorie AAF
Neocate Active®
unflavoured/blackcurrant
(Nutricia)
from birth
400g = £23.00
from birth
400g = £26.80
from birth
400g = £28.30
from one year
945g = £66.60
Neocate Advance®
from one year
unflavoured/banana/vanilla
(Nutricia)
750g = £46.35
1,000g = £58.60
Please see appendix 1
(p12) for information
relating to calcium
supplementation.
This is a high calorie
formula and is not
suitable for all infants
over 1 year. It is not
suitable as a sole source
of nutrition.
This is a sole source of
nutrition for children with
CMPA aged 1-10 years.
It is a high calorie formula
that is not suitable for all
infants over 1 year.
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Soya Formulae
Soya formula
Notes
Cost

430g = £5.32
860g = £10.15
(September 2015)
®
SMA Wysoy
Should not be prescribed for:
o Infants below 6 months old due
to the high phytoestrogen
content.
o Infants with soya allergy and
CMPA
 Should only be considered for infants
with CMPA over 6 months if they are
unable to tolerate EHF or AAF, due to
the risk of the infant with CMPA
developing allergy to soya.
 Parents should be advised to
purchase soya formula as it is a
similar cost to cows’ milk formula and
is readily available.
Alpro Junior 1+
soya milk
Calcium enriched
soya/oat milk
Alternative milk
suitable for CMPA
& lactose
Intolerance
Oat milk
Coconut milk
Almond milk
from 1 year
from 2 years
Examples of brands
(suitable from 2 years)
Alpro, Oatley,
Alpro, Koko, Tesco Free From
Alpro, Tesco Free From
Available in
supermarkets
Available in
supermarkets
Cost
Available in
supermarkets
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Formulae and milks that should not be used for CMPA
The following formulae and milks are NOT suitable for infants with CMPA:




Lactose free formulas: SMA LF®, Enfamil O-Lac®
Goats’ milk
Sheeps’ milk
Rice milk (unsuitable under age 4 ½ due to arsenic content).
Quantities to prescribe

Prescribe only 1 or 2 tins initially until compliance/tolerance is established to
avoid waste.

Unless there is anaphylaxis, advise parents to introduce the new formula
gradually by mixing with the usual formula used in increasing quantities until
the transition is complete. Serving in a closed cup or bottle, or with a straw
(depending on age) may improve tolerance. Reason: EHF and AAF have an
unpleasant taste and smell, which is better tolerated by younger patients (<6
months).

Note that stool colour and consistency may change.

Calcium supplementation may be needed for children over one year
depending on volume and type of formula taken. It is rarely required in infants
younger than this. The paediatric dietitian will advise.
Age of child
Number of tins for 28 days
Under 6 months
13 x 400g tins
or
6 x 900g tins
6 – 12 months
7 - 13 x 400g tins
or
3 - 6 x 900g tins
Over 12 months
7 x 400g tins
or
3 x 900g tins
Some children may require larger quantities e.g. faltering growth. Review
recent correspondence from the paediatrician or paediatric dietitian
Amounts based on:
o Infants under 6 months being exclusively formula fed and drinking
150ml/kg/day of a normal concentration.
o Infants 6 - 12 months requiring less formula as solid food intake increases.
o Children over 12 months drinking the 600mls of milk substitute per day
recommended by the Department of Health.
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Referral to paediatric dietitian and specialist
services
Most infants with CMPA can be managed in primary care until weaned.
 All children with CMPA should be reviewed by a paediatric dietitian to ensure
nutritional adequacy of the diet (NICE CG116, 2011).
 Based on the allergy-focused clinical history, consider referral to secondary or
specialist care in any of the following circumstances (NICE guidelines CG116;
2011; Ludman S, et al; 2013):
o Faltering growth in combination with one or more of the gastrointestinal
symptoms mentioned on page 4.
o Not responded to a single-allergen elimination diet.
o Had one or more acute systemic reactions.
o Had one or more severe delayed reactions confirmed IgE-mediated food
allergy and concurrent asthma?
o Significant atopic eczema where multiple or cross-reactive food allergies
are suspected by the parent or carer.
o Persisting parental suspicion of food allergy (especially in children or
young people with difficult or perplexing symptoms) despite a lack of
supporting history.
o Diagnostic uncertainty or clinical suspicions of IgE-mediated food allergy
but allergy test results are negative.
o Clinical suspicion of multiple food allergies.
o Incomplete resolution after cows’ milk protein has been excluded.
o Complex symptoms.
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Reviewing and discontinuing treatment
Review prescriptions regularly to check that the formula prescribed is appropriate
for the child’s age and nutritional requirements.
Avoid adding to the repeat template since quantities required will change with age
(see notes above). Refer to recent correspondence from the paediatric dietitian.
Outgrowing CMPA: 60-75% of children with delayed reactions outgrow their cows’
milk protein allergy by 2 years of age. This figure rises to 85-90% of children at 3
years of age. Children with immediate allergic reactions to cows’ milk tend to
outgrow their milk allergy slower with only 50% tolerating cows’ milk by their 5th
birthday.
Challenging with cows’ milk protein: Refer to NICE guidelines (CG116; 2011)
regarding which children should be challenged with cow’s milk protein in a secondary
care setting.
Review the need for the prescription. If you can answer ‘yes’ to any of the
following questions, the child should be reviewed by the paediatric dietitian and/or
paediatrician to assess whether cow’s milk allergy is still present and formula is still
required or if any other supplementation is needed. Please send a new referral or
liaise with appropriate services if the child is already under the care of a paediatric
dietitian.




Is the patient over 2 years of age?
Has the formula been prescribed for more than 1 year?
Is the patient prescribed more than the suggested quantities of formula
according to their age?
Is the patient able to eat any of the following foods: cows’ milk, cheese,
yoghurt, ice cream, custard, cakes, chocolate, cream or other foods
containing cows’ milk
Children with multiple or severe allergies may require prescriptions beyond 2
years. This should always be on the recommendation of the paediatric dietitian.
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References and evidence
1. Venter C, Arshad SH (2011). Epidemiology of food allergy. Pediatr Clin North
Am; 58(2): 327 – 49.
2. Fiocchi A, et al (2010). World Allergy Organisation (WAO) Diagnosis and
Rational for action against Cow’s Milk Allergy (DRAMCA) guidelines. Pediatr
Allergy immunol; Suppl 21:1-125.
3. NICE Guidelines, clinical guidelines 116 (2011). Food allergy in children and
young people.
4. Vandenplas Y et al (2007). Guidelines for the diagnosis and management of
cow’s milk protein allergy in infants: Arch Dis Child; 92: 902-908.
5. Allen KJ, Davidson GP, Day AS, et al. Management of cows’ milk protein
allergy in infants and young children: An expert panel perspective. J Paediatr
Child Health 2009;45:481-8
6. LPP (2013). Paediatric nutritional products Appropriate prescribing resource
pack.
7. Ludman S, Shah N, Fox AT (2013). Managing Cow’s Milk Allergy in Children.
BMJ; 347:f5424
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Appendix 1:
Quick reference guide to calcium supplementation
with amino acid formulae
Please note where an AAF is indicated, the most cost effective and suitable option
may depend on whether the infant requires a calcium supplement.
Advice should be given to the parents to ensure the infant follows an appropriate
exclusion weaning diet whilst on an amino acid formula. This should include advice
on appropriate dietary sources of calcium and whether a supplement is required.
Guidance on calcium supplementation for AAF
Product name
Neocate LCP
Alphamino
Nutramigen
Puramino
Formulation
400g tin
400g tin
400g tin
Volume needed to meet
RNI for calcium
<6months
810mls
930mls
825mls
Amount of Ca2+ from
600mls
393mg
339mg
384mg
Cost per 100kcal
£1.46
£1.14
£1.34
NB – RNI for Calcium in infants 0-12month is 525mg. For children 1-3 years it drops
to 350mg.
A calcium supplement may be required for infants taking extensively hydrolysed
formulae but dairy alternative products (e.g. soya/oat) may be introduced at weaning
to supplement the levels from the formula.
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Appendix 2: Quick reference guide to managing infants with
cow’s milk protein allergy
Start extensively hydrolysed
formula (EHF)
Child has symptoms of CMPA (see page 5)
No
Breastfeeding?
First line: Similac Alimentum®
Anaphylactic symptoms
OR
Yes
Continue breastfeeding
Minimum 2 week
exclusion of cow milk
protein from mother’s
diet
No
OR
AND
Previously reacted to cow’s
milk via breast milk
Refer to paediatric dietitian
Yes
Start amino acid
formula (page 7)
If top up for formula
required, use EHF (page
6)
AND
No
Symptoms resolved
within 4 weeks?
Refer to
paediatric dietitian
Symptoms
resolved?
Calcium
supplement
(mother)
AND
Yes
Refer to
secondary allergy
service
Yes
No
Lactose containing - Only use if
no GI symptoms. See page 6
Faltering growth plus severe
GI symptoms / severe
atopic eczema
Consider 1000m g / day
calcium supplement
(mother)
Mother to continue
breast feeding?
Alternatives: See page 6
Continue EHF
No
Yes
Monitoring
Continue
breast
feeding
Stop cow’s
milk protein
exclusion
diet
Further
investigation
Continue breast
feeding
Continue cow’s milk
protein exclusion
diet (mother)
Consider
1000mg/day calcium
supplement (mother)
Refer to paediatric
dietitian
Review prescription regularly to check that formula is:
o
o
o
age appropriate
prescribed in correct quantity
still required
 Child > 2yrs?
 Prescribed for > 1yr?
 Prescribed more than the quantity
suggested for age?
 Child able to tolerate cow’s milk protein
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containing products (page 11)